90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product… — Class II medical device recall Z-1534-2013
Terminated recall by OrthoPediatrics Corp, reported 2013-06-19, distributed nationwide. Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five re
| Recall number | Z-1534-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OrthoPediatrics Corp, Warsaw, IN, United States |
| Recall initiated | 2013-04-19 |
| Classified | 2013-06-12 |
| Reported by FDA | 2013-06-19 |
| Terminated | 2013-09-19 |
| Distributed | Nationwide (US) |
| Quantity | 130 devices |
| Model numbers | 00-1200-1000 |
Product
90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies.
Reason for recall
Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1534-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.